TARLODIX PLUS 10 mg/10 mg/25 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules

amlodipine/ramipril/hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Tarlodix Plus is and what it is used for
2. What you need to know before taking Tarlodix Plus
3. How to take Tarlodix Plus
4. Possible side effects
5. Storage of Tarlodix Plus
6. Package contents and additional information

1. What Tarlodix Plus is and what it is used for

Tarlodix Plus contains three active substances called amlodipine, ramipril, and hydrochlorothiazide.

Ramipril belongs to a group of medications called ACE inhibitors (Angiotensin-Converting Enzyme inhibitors). It works as follows:

• By reducing the production of substances that could increase blood pressure.
• By making your blood vessels relax and widen.
• By making your heart pump blood more easily.

Amlodipine belongs to a group of medications called calcium antagonists. It works as follows:

• By relaxing and widening your blood vessels, allowing blood to pass through them more easily.

Hydrochlorothiazide belongs to a group of medications called "thiazide diuretics". It works as follows:

• By increasing urine production, which also decreases your blood pressure.

This medication can be used to treat high blood pressure (hypertension) in adult patients whose blood pressure is adequately controlled with amlodipine, ramipril, and hydrochlorothiazide administered separately at the same time and at the same dose as the combination presented in this medication.

2. What you need to know before you start taking Tarlodix Plus

Do not take Tarlodix Plus:

• if you are allergic to amlodipine, ramipril, or hydrochlorothiazide (active substances), other calcium antagonists, or ACE inhibitors, or any of the other components of this medicine (listed in section 6). It may cause itching, skin redness, or difficulty breathing.
• if you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to supply enough blood to the body).
• if you have ever had a severe allergic reaction called "angioedema". Symptoms include itching, hives, red marks on the hands, feet, and throat, inflammation of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, treatment with this medicine may not be suitable for you.
• if you have severe kidney problems
• if you are unable to urinate (anuria).
• if you have gout.
• if you have liver failure.
• if you have kidney problems that reduce blood supply (renal artery stenosis).
• during the last 6 months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").
• if your blood pressure is abnormally low or unstable.
• if you have heart failure after a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Do not take Tarlodix Plus if you have any of the above circumstances. If you are not sure, consult your doctor or pharmacist before taking Tarlodix Plus.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tarlodix Plus.

Tell your doctor if any of the following situations apply to you:

• if you are an elderly person and need a dose increase.
• if you have heart, liver, or kidney problems.
• if you have had a recent heart attack.
• if you have severe increases in blood pressure (hypertensive crises).
• if you have lost a large amount of salts or fluids due to vomiting, diarrhea, excessive sweating, low-salt diets, or long-term use of diuretics, or if you are undergoing dialysis.
• if you are breastfeeding.
• if you suffer from allergies or asthma.
• if you are going to undergo treatment to reduce your allergy to bee or wasp stings (desensitization).
• if you are going to be given an anesthetic, for example, in a dental operation. You may need to stop taking Tarlodix Plus a day in advance; consult your doctor or pharmacist.
• if you have high levels of potassium in your blood (shown in blood test results).
• if your potassium level in your blood is too low (with or without symptoms such as muscle weakness, muscle spasms, or abnormal heart rhythm).
• if your sodium level in your blood is too low (with or without symptoms such as fatigue, confusion, muscle spasms, or convulsions).
• if you are taking medicines or have a disease that can lower your sodium levels in the blood. Your doctor should perform regular blood tests, particularly to check your sodium levels in the blood, especially if you are an elderly patient.
• if your calcium levels in your blood are high (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness, or muscle contractions).
• if you suffer from gout attacks (uric acid crystals in the joints).
• if you are taking any of the following medicines, as they increase the risk of angioedema:
• • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.
• if you have a vascular disease of collagen, such as scleroderma or systemic lupus erythematosus.
• if you have a decrease in your vision or have eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), especially if you are at risk of developing a condition called glaucoma or are allergic to medicines containing penicillin or sulfonamide.
• if you have photosensitivity reactions, you should stop taking this medicine.
• if you have diabetes, your insulin dose may need to be adjusted or oral hypoglycemic agents may be required.
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • Angiotensin II Receptor Antagonists (ARA) (e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medicine.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Tarlodix Plus, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information "Do not take Tarlodix Plus".

Tell your doctor if you think you are (or might be) pregnant. Tarlodix Plus is not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

Tarlodix Plus is not recommended for children and adolescents under 18 years of age because there is no information available on safety and efficacy for this population.

Other medicines and Tarlodix Plus

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Tarlodix Plus" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines, as they may reduce the effect of Tarlodix Plus:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure.
• Medicines that stimulate the heart, such as isoproterenol, dobutamine, dopamine, or epinephrine.
• Rifampicin (an antibiotic used to treat tuberculosis).
• Hypericum perforatum (St. John's Wort used to treat depression).
• Chelating resins (substances used mainly to treat high lipid levels in the blood).

Tell your doctor if you are taking any of the following medicines, as they may increase the risk of side effects if taken with Tarlodix Plus:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, and acetylsalicylic acid).
• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 "Do not take Tarlodix Plus").
• Medicines used to prevent organ rejection after a transplant, such as cyclosporin.
• Medicines that can lower the amount of potassium in the blood. These include medicines for constipation (laxatives), glucocorticoids, tetracosactide, amphotericin B (used for fungal infections), and ACTH (used to evaluate if your adrenal glands are functioning properly).
• Diuretics (water pills) such as furosemide.
• Desmopressin (used in case of diabetes or urinary problems).
• Corticosteroid medicines for inflammation, such as prednisolone.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics such as spironolactone, triamterene, amiloride, and other medicines that can increase the amount of potassium in the blood (e.g., trimethoprim alone or in combination with sulfamethoxazole for bacterial infections and heparin (to thin the blood).
• Calcium tablets or other calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Colestyramine (to reduce fat levels in the blood).
• Carbamazepine, oxcarbazepine (for epilepsy).
• Ketoconazole, itraconazole (antifungal medicines).
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV).
• Verapamil, diltiazem (medicines used to treat heart disorders or high blood pressure).
• Dantrolene (in infusion for severe body temperature abnormalities).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used against diarrhea).
• Tacrolimus (used to control the body's immune response to allow it to accept a transplanted organ).
• Other products that lower blood pressure, such as phosphodiesterase type 5 inhibitors (for erectile dysfunction), nitrates, alpha-blockers (for urological use to reduce muscle tension in the prostate and urethra), other medicines used to treat prostate disorders (alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin), tricyclic antidepressants, neuroleptics, phenothiazines, dopamine agonists, levodopa used in Parkinson's disease, baclofen (to treat muscle stiffness in diseases such as multiple sclerosis), amifostine.
• Medicines that alter gastrointestinal motility, i.e., anticholinergic agents.
• Citalopram, escitalopram (used for depression).
• Difemanil (used in the treatment of peptic ulcer, gastric hyperacidity, and in the treatment of hyperhidrosis (excessive sweating)).
• Medicines used to treat heart rhythm disorders (e.g., digitalis, dofetilide, ibutilide, hydroquinidine, disopyramide, amiodarone, dronedarone, sotalol, digoxin, quinidine).
• Pentamidine (used to treat pneumonia caused by a fungus called Pneumocystis carinii).
• Medicines used to treat schizophrenia and psychosis (e.g., amisulpride, chlorpromazine, ciamemazine, flupentixol, flufenazine, haloperidol, pipamperone, pipotiazine, sulpiride, sultoprida, zuclopentixol).
• Pimozide (used in Tourette's syndrome).
• Hydroxyzine (used to treat itching caused by allergies).
• Medicines used against nausea and vomiting (e.g., domperidone, dolasetron, droperidol, levomepromazine.
• Medicines used to treat malaria (e.g., artenimol, chloroquine, halofantrine, lumefantrine, piperaquine).
• Medicines used to treat allergic reactions (e.g., mizolastine, mequitazine).
• Antibiotics used to treat infections (e.g., amphotericin B, clarithromycin, erythromycin, levofloxacin, moxifloxacin, penicillin, spiramycin).
• Methadone (used to treat dependence on certain active substances).
• Prucalopride (used to treat chronic constipation).
• Tiaprida (used to reduce excessive sweating, agitation, and tremors during alcohol withdrawal).
• Vandetanib, toremifene (used to treat certain types of cancer) and other cancer medicines (chemotherapy).
• Vincamine (used to treat neurological disorders related to aging).

Tell your doctor if you are taking any of the following medicines, as they may be affected by Tarlodix Plus:

• Medicines for diabetes, such as oral hypoglycemic agents or insulin. Tarlodix Plus may lower your blood sugar levels. Check your blood sugar levels while taking Tarlodix Plus.
• Lithium (for mental health problems): Tarlodix Plus may increase the amount of lithium in your blood. Your doctor should closely monitor the amount of lithium in your blood.
• Simvastatin (a cholesterol-lowering medicine): Amlodipine may increase the amount of simvastatin in your blood. Your doctor may need to reduce the dose of simvastatin if you take Tarlodix Plus.
• Quinine (for malaria).
• Medicines that contain iodine (contrast medium), which may be used when you have an examination or X-ray in the hospital.
• Medicines used to thin the blood that you take by mouth (oral anticoagulants) such as warfarin.

If any of the above circumstances apply to you (or you are not sure), talk to your doctor or pharmacist before taking Tarlodix Plus.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Tarlodix Plus with food, drinks, and alcohol

• Tarlodix Plus can be taken with or without food.
• Grapefruit or grapefruit juice should not be consumed by people taking Tarlodix Plus. This is because grapefruit and grapefruit juice can lead to an increase in the levels of amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of this medicine.
• Drinking alcohol with Tarlodix Plus may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking Tarlodix Plus, talk to your doctor or pharmacist. Talk to your doctor about how blood pressure medicines and alcohol can have additive effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should tell your doctor if you think you are (or might be) pregnant. You should not take Tarlodix Plus in the first 12 weeks of pregnancy and should not take it at all after the 13th week, as its use during pregnancy may be harmful to the baby. If you become pregnant during treatment with Tarlodix Plus, inform your doctor immediately. If you are planning to become pregnant, consult your doctor, as they will advise you to take another medicine.

Breastfeeding

You should not take Tarlodix Plus during breastfeeding. You should tell your doctor if you are breastfeeding or are about to start breastfeeding before taking Tarlodix Plus.

Consult your doctor or pharmacist before taking any medicine.

Fertility

There is not enough data on the effect on fertility.

Driving and using machines

This medicine may affect your ability to drive or use machines. If you feel unwell, dizzy, tired, or have a headache while taking this medicine, do not drive or use machines and contact your doctor immediately.

Tarlodix Pluscontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

3. How to take Tarlodix Plus

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication should be taken once a day.

Your doctor may modify the dose depending on the effect it has on you.

Take this medication at the same time of day, before or after meals.

Swallow the capsule whole with some liquid.

Do not crush or chew the capsules forcefully.

Do not take this medication with grapefruit juice.

Hepatic and renal insufficiency

In hepatic and renal insufficiency, the doses may be modified.

Elderly patients

Your doctor will reduce the initial dose and adjust the treatment slowly.

Use in children and adolescents

The use of this medication is not recommended in children and adolescents under 18 years of age, as there are no safety and efficacy data available for this population.

If you take moreTarlodix Plus than you should

Taking too many capsules can cause your blood pressure to be low or dangerously low. You may feel dizzy or weak, and if the drop in blood pressure is severe enough, you may suffer from shock. Your skin may feel cold and damp, and you may lose consciousness. Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion. Inform your doctor or go to the emergency department of the nearest hospital if you take too much Tarlodix Plus. Do not drive to the hospital, have someone drive you or call an ambulance. Bring the medication packaging with you to indicate to the doctor what you have taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tarlodix Plus

If you forget to take a capsule, leave that capsule and take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Tarlodix Plus

Your doctor will indicate how long you should take this medication. Your condition may recur if you interrupt treatment with this medication before your doctor indicates.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people suffer from them.

Stop taking Tarlodix Plus and consult a doctor immediately if you notice any of the following serious side effects, you may need urgent medical treatment:

• Swelling of the face, lips, or throat that makes swallowing or breathing difficult, as well as itching and skin rash. This could be a sign of a severe allergic reaction to Tarlodix Plus.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).
• Acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion) (a very rare side effect that can affect up to 1 in 10,000 people).
• Sudden sunburn or dermatitis (a dry, bumpy, or blistering rash) on sun-exposed skin.

Consult your doctor immediately if you experience:

• Sudden wheezing, shortness of breath, or difficulty breathing, faster heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems such as heart attack and stroke.
• Difficulty breathing or coughing. These may be symptoms of lung problems, including inflammation.
• Bruises, bleeding longer than usual, any sign of bleeding (e.g., bleeding gums), purpura, rash, or spots on the skin, or getting infections more easily than usual, sore throat, and fever, feeling tired, weakness, dizziness, or having pale skin. These may be signs of blood or bone marrow problems.
• Severe stomach pain that can reach the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Extreme fatigue (fatigue), nausea, and vomiting, confusion, or concentration problems, swelling (edema), especially around the hands, ankles, or face, urinating more frequently, cramps (muscle spasms). These may be signs of kidney failure.
• Unusual growths or spots on the skin, especially in sun-exposed areas. They may be signs of non-melanoma skin cancer.

Other side effects:

Tell your doctor if any of the following symptoms worsen or last more than a few days.

Very common: may affect more than 1 in 10 people

• Fluid retention (edema)
• Hypokalemia
• Hyperlipidemia

Common: may affect up to 1 in 10 people

• Headache, dizziness, numbness associated with drowsiness (somnolence; especially at the beginning of treatment), feeling of exhaustion (fatigue)
• Awareness of heartbeats (palpitations)
• Swelling of the ankles
• Low blood pressure (hypotension), especially when standing or sitting up quickly (decreased orthostatic blood pressure), fainting (syncope), flushing
• Dry cough, sinus inflammation (sinusitis) or bronchitis, difficulty breathing (dyspnea)
• Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders, and abdominal discomfort (including dyspepsia), nausea, vomiting, alteration of bowel habits (including diarrhea or constipation), loss of appetite (anorexia), spasms
• Skin rash with or without inflammation, hives
• Chest pain
• Muscle cramps or pain (myalgia)
• Blood tests showing low magnesium and sodium levels in the blood
• Feeling weak and powerless (asthenia)
• Blood tests showing a decrease in the number of platelets (thrombocytopenia)
• Blood tests showing an increased amount of uric acid or more potassium than normal in the blood
• Impotence
• Visual disturbances (including double vision and blurred vision)

Uncommon: may affect up to 1 in 100 people

• Skin swelling, mucous membrane, and surrounding tissue (angioedema/Quincke's edema; very exceptionally, the resulting respiratory tract obstruction from angioedema can have a fatal outcome)
• Swollen arms and legs (peripheral edema; this may be a sign that your body is retaining more water than normal)
• Intestinal swelling (small intestine angioedema)
• Mood changes, depression, anxiety, nervousness, restlessness, sleep disorders (insomnia)
• Ringing in the ears (tinnitus)
• Sneezing/nasal secretion (rhinitis), stuffy nose
• Breathing difficulties (bronchospasm), including worsening of asthma
• Dry mouth, upper abdominal pain, including gastritis
• Pancreas inflammation (pancreatitis; fatal cases have been reported with ACE inhibitors)
• Kidney failure, including acute kidney failure (significant decrease in diuresis, urinary disorders, urinating more than usual during the day, increased need to urinate at night (nocturia)
• Presence of glucose in urine
• Worsening of pre-existing proteinuria (more protein than usual in the urine)
• Feeling unwell (malaise)
• Weight gain or loss
• Dizziness, tremors
• Hair loss (alopecia)
• Itching (pruritus), small bleeding spots or bleeding areas on the skin (purpura), skin discoloration, exanthema
• Unusual skin sensations such as numbness, tingling, pinching, burning, or tingling on the skin (paresthesia), reduced skin sensation (hypoesthesia)
• Loss (ageusia) or change in the taste of things (dysgeusia)
• Excessive sweating (hyperhidrosis)
• Heart attack (myocardial infarction), heart vessel disease (myocardial ischemia), chest tightness, and pain (angina pectoris), increased (tachycardia) or irregular heartbeats (arrhythmia)
• Reduced heart rate (bradycardia), cardiac rhythm disorders (designated atrial fibrillation, ventricular tachycardia)
• Joint pain (arthralgia), back pain, general pain
• Increased body temperature/fever (pyrexia)
• Reduced sexual desire in men or women, male breast enlargement (gynecomastia)
• An increased number of certain white blood cells (eosinophilia) found during a blood test
• Blood tests showing changes in liver (increased liver enzymes and/or conjugated bilirubin), pancreas (increased pancreatic enzymes), or kidney (increased creatinine) function
• Cough
• Inflammation of blood vessels, often with skin rash (vasculitis, cutaneous vasculitis)

Rare: may affect up to 1 in 1,000 people

• Feeling confused or disoriented, balance disorders
• Red and swollen tongue (glossitis)
• Skin inflammation and peeling (exfoliative dermatitis)
• Nail problems, such as weakness or separation of the nail from its bed (onycholysis)
• Red, itchy, swollen, or tearful eyes (conjunctivitis)
• Hearing problems
• Yellowing of the skin (cholestatic jaundice), liver cell damage
• Narrowing of blood vessels (vascular stenosis)
• Altered blood flow (hypoperfusion)
• Blood tests showing a decrease in the number of red blood cells, white blood cells, and platelets (including neutropenia or agranulocytosis, leucopenia) or a decrease in hemoglobin levels
• Blood tests showing an increased amount of sugar than normal in the blood. If you have diabetes, this can worsen your diabetes
• Sensitivity to light or sun (photosensitivity)
• Hypercalcemia
• Hypersensitivity reaction
• - Inflammation of blood vessels accompanied by symptoms such as skin rash, purple and red spots on the skin, fever (necrotizing vasculopathy)

Very rare: may affect up to 1 in 10,000 people

• Widespread skin rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• Liver inflammation (hepatitis, in most cases with cholestasis)
• Skin rash that can form blisters and looks like small white spots (erythema multiforme)
• Lupus-like reaction, lupus reactivation, necrotizing vasculitis, and toxic epidermal necrolysis
• Gingival overgrowth (gingival hyperplasia)
• Increased muscle tone (hypertonia)
• Peripheral nervous system disease (peripheral neuropathy)
• Bone marrow failure
• Blood tests showing damaged red blood cells (hemolytic anemia)
• Allergic reactions
• Hypochloremic alkalosis
• Breathing difficulties (including pneumonitis and pulmonary edema)

Frequency not known: frequency cannot be estimated from available data

Tell your doctor if any of the following symptoms worsen or last more than a few days.

• Blood tests showing very few red and white blood cells and platelets (pancytopenia)
• Anaphylactic or anaphylactoid reactions
• Pemphigus (gritty skin)
• Increased antinuclear antibodies
• Disturbance in attention
• Oral mucosa inflammation with small ulcers (aphthous stomatitis)
• Aplastic anemia
• Fingers and toes changing color when cold and tingling or painful sensation with heat (Raynaud's phenomenon)
• Cerebral ischemia, including ischemic stroke and transient ischemic attack
• Impaired psychomotor skills
• Burning sensation
• Change in the way things smell (parosmia)
• Acute liver failure, cholestatic and cytolytic hepatitis (exceptionally, a fatal outcome has been reported)
• Skin inflammation (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid exanthema), worsening of skin peeling or skin peeling (psoriasis exacerbation), mucosal rash (enanthema)
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible
• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait
• Sudden decrease in distant vision (acute myopia), decrease in vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• Skin and lip cancer (non-melanoma skin cancer)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's Pharmacovigilance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Tarlodix Plus

Keep this medication out of sight and reach of children.

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofTarlodix Plus

The active ingredients are: amlodipine, ramipril, and hydrochlorothiazide.

Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besylate), 5 mg of ramipril, and 12.5 mg of hydrochlorothiazide.

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besylate), 5 mg of ramipril, and 25 mg of hydrochlorothiazide.

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules:

One capsule contains 5 mg of amlodipine (6.934 mg as amlodipine besylate), 10 mg of ramipril, and 25 mg of hydrochlorothiazide.

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules:

One capsule contains 10 mg of amlodipine (13.868 mg as amlodipine besylate), 10 mg of ramipril, and 25 mg of hydrochlorothiazide.

The other components are:

Capsule content:microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized corn starch, sodium potato carboxymethyl starch (type A), sodium stearyl fumarate, and sodium.

Capsule shell:red iron oxide (E172), titanium dioxide (E171), gelatin, black iron oxide (E172) (only for 5 mg/5 mg/12.5 mg and 10 mg/10 mg/25 mg doses), and yellow iron oxide (E172) (only for 5 mg/5 mg/25 mg, 5 mg/10 mg/25 mg, and 10 mg/10 mg/25 mg doses).

Product appearance and packaging contents

Tarlodix Plus 5 mg/5 mg/12.5 mg are hard capsules: capsule with opaque pink cap and light gray body.

Tarlodix Plus 5 mg/5 mg/25 mg are hard capsules: capsule with opaque pink cap and ivory body.

Tarlodix Plus 5 mg/10 mg/25 mg are hard capsules: capsule with dark pink cap and yellow body.

Tarlodix Plus 10 mg/10 mg/25 mg are hard capsules: capsule with brown cap and caramel body.

Tarlodix Plus is available in packages of 10, 28, 30, 60, or 100 hard capsules in blister packs in cardboard boxes.

Only some package sizes may be marketed.

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 - 2ª planta

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medication is authorized in the Member States of the European Economic Area with the following names:

Denmark: Ramipril/Amlodipin/Hydrochlorthiazid APC

Spain: Tarlodix Plus 5 mg/5 mg/12.5 mg hard capsules

Tarlodix Plus 5 mg/5 mg/25 mg hard capsules

Tarlodix Plus 5 mg/10 mg/25 mg hard capsules

Tarlodix Plus 10 mg/10 mg/25 mg hard capsules

Date of the last revision of this leaflet: December 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es.